Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

Exclusion Criteria

• •DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
• •Mental retardation or amnestic or other cognitive disorders
• •Significant suicide risk:
• •Suicide attempt within the past year OR
• •Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))
• •Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
• •Use of prohibited concomitant medication that cannot be discontinued
• •Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
• •Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2X the upper limit of normal (ULN)
• •Clinically significant cardiovascular disorders
• •Seizure disorder or risk of seizure
• •Drug or alcohol abuse or dependence (within the past year)
• •Positive urine drug screen or blood alcohol